Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
FDA Recall Z-1015-05 · Posted 2005-07-16
Recalling FirmDiagnostic Products Corp
Recall StatusTerminated
Product CodeDHX
Date Initiated2005-05-26
Date Terminated2006-02-03
Product Quantity269
Reason for Recall
Adverse trend in stability, controls biased or out of range.
Firm Action
Recall was initiated by phone using a script, to be followed up with a letter and response form.
Root Cause
Other
Distribution Pattern
Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.